1. Field of the Invention
The present invention relates to urinary catheters. More specifically, the present invention relates to sealing a reservoir of a catheter.
2. Background of the Invention
Intermittent catheterization of a individual's urinary bladder is a common practice today for many persons who are in a hospital setting, a nursing home, doctor's office, rehabilitation facility, or at home. For instance, a patient is sometimes catheterized to treat such conditions as urinary retention, the inability to evacuate urine, or for the purpose of obtaining a sterile urine specimen from a patient in a doctor's office or at home.
The need for intermittent catheterization of an individual sometimes arises due to problems typically associated with long term use of indwelling catheters, such as infections, urethral damage, and bladder damage. Long term use of an indwelling catheter is also a risk factor for bladder cancer. This is often the case for persons having a neurogenic urinary condition (neurogenic bladder), such as in a spinal cord injury, multiple sclerosis, stroke, or brain injury. Conditions that interfere with the individual's ability to voluntarily void the bladder may also arise post-surgically or as a result of benign prostatic hypertrophy, prostate cancer or diabetes mellitus. Many of the affected individuals are capable of, and would prefer to perform, self-catheterization. For many, the level of risk and discomfort of repeated catheterizations carried out over the course of a day (at 3-6 hour intervals, for example) are offset by the accompanying convenience, privacy or self-reliance that is achieved. Some of the major difficulties that arise in self-catheterization are the lack of satisfactory catheterization kits, the problem of maintaining the required level of sanitation during the procedure, and the difficulty of sometimes performing the procedure under conditions of restricted space and privacy.
In assisted catheterizations, or non self-catheterizations, it is common practice in hospitals to employ a catheterization tray, which typically includes a sterile drape, gloves, a conventional catheter, antiseptic solution, swabs, lubricant, forceps, underpad, and a urine collection container. Assisted catheterization is usually performed with the patient in a supine position. Maintaining a sterile field during the procedure can still be a problem, however, and the “cath tray” procedure is impractical for use with some individuals and situations today.
Many individuals with spinal cord injuries or other neurological diseases routinely perform intermittent catheterization several times a day using conventional catheters or kits and “clean technique.” Clean technique means that the urethral area is initially wiped with a moist soapy washcloth, and efforts are made to avoid contamination of the catheter during the procedure. The user's hands are not sterile and a sterile field is not maintained. Clean technique is used instead of sterile technique, generally, for two reasons. First, it is very difficult, if not impossible, for individuals who are performing self-catheterization to adhere strictly to sterile technique. Secondly, these individuals are required to catheterize themselves between 3 and 6 times a day. Sometimes an individual will reuse a “cleaned” catheter. As a result, the use of non-sterile technique will many times result in contamination and subsequent infection of the urinary tract, causing significant morbidity and cost to the patient and society.
In most closed-system sterile units the collection bag doubles as a sterile cover. These catheters are extremely difficult for the user to grasp and insert. Many of these closed-system catheters have a cap that covers the introducer tip to maintain sterility. This is particularly a problem for self-catheterization users who may also have neurological problems that limit manual dexterity, because they have difficulty removing the cap. Also, with some of the available catheter kits and methods, the catheter is either not sufficiently lubricated during insertion (and thus requires the additional application of possibly non-sterile lubricant), or the catheter is too slick with lubricant and cannot effectively be grasped through an insufficiently flexible bag. As a practical matter, many individuals who would prefer to self-catheterize cannot conveniently do so, and maintain the required level of sanitation using many of the existing catheterization apparatus.
Many catheterization tasks require a degree of dexterity to accomplish. People with normal dexterity, like paraplegics, may not have use of their lower extremities, but their hands are normal. Some quadriplegics can have use of their upper extremities, having absolutely normal movement, like a paraplegic, except they lack normal hand dexterity. Thus, many tasks requiring a degree of hand dexterity are very difficult for quadriplegics to accomplish.
Spinal cord injuries at the fifth, sixth, and seventh cervical vertebrae level (C5, C6, C7) affect the use of a person's hands and make these tasks difficult or impossible with current products. However, people who have had strokes, brain injuries, or multiple sclerosis may also require catheterization but have limited dexterity. The current catheterization market does not currently support the needs of these people.
Insertion of a lubricated catheter is one such task. Devices currently on the market allow for different ways of lubricating a catheter. However, most of these closed-system catheter units have gel covering the catheter within the bag, which makes it difficult or impossible to grasp with limited dexterity and insert into the bladder. Another problem with the current closed-system catheters is that the catheter may not be circumferentially lubricated or the gel may be wiped away as it is pushed through the non-lubricated introducer tip. This can lead to urethral irritation, “sticking”, and discomfort or pain for the recipient. What is needed is a catheter device, system, or method that contains a lubricant in an airtight gel-reservoir and a mechanism that lubricates the track of the introducer that the catheter travels through prior to entering the urethra. The cap that covers the introducer tip must be tight enough to prevent air leakage and subsequent drying out of the gel in the reservoir, but must also be easy to remove by someone with limited dexterity.